Amphoject
Generic Name
Amphotericin B for Injection
Manufacturer
Bharat Parenterals
Country
India
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| amphoject 50 mg injection | ৳ 15,000.00 | N/A |
Description
Overview of the medicine
Amphoject 50 mg Injection contains Amphotericin B, an antifungal medication used to treat serious, potentially life-threatening systemic fungal infections.
Uses & Indications
Dosage
Adults
Dosage is individualized based on the patient's condition and tolerance. Typically, an initial test dose is given, followed by daily doses ranging from 0.25 to 1.5 mg/kg/day, administered as a slow intravenous infusion over 2-6 hours.
Elderly
Similar to adult dosage, but with close monitoring of renal function due to age-related decline in kidney function.
Renal_impairment
Dose adjustment may be necessary. Initiate with lower doses and monitor renal function (BUN, creatinine) frequently. The dose may be reduced or administration frequency adjusted.
How to Take
Amphoject 50 mg is administered as a slow intravenous infusion, typically over 2-6 hours. It must be diluted in 5% Dextrose Injection, USP, to a final concentration of no more than 0.1 mg/mL. A test dose is usually given prior to the first full dose to assess patient tolerance and potential for infusion-related reactions.
Mechanism of Action
Amphotericin B binds to ergosterol, a component of the fungal cell membrane, leading to increased membrane permeability, leakage of intracellular components, and ultimately cell death.
Pharmacokinetics
Onset
Rapid (initial antifungal effect occurs within hours of IV administration).
Excretion
Slowly excreted via the kidneys, with a small amount excreted in the bile. It is not significantly removed by hemodialysis.
Half life
Initial half-life of about 24 hours, followed by a slower terminal elimination half-life of approximately 15 days.
Absorption
Poorly absorbed from the gastrointestinal tract; therefore, it must be administered intravenously for systemic effect.
Metabolism
Not extensively metabolized. The metabolic pathways are largely unknown.
Side Effects
Contraindications
- Patients with known hypersensitivity to Amphotericin B or any component of the formulation.
Drug Interactions
Flucytosine
Amphotericin B can enhance the toxicity of flucytosine by increasing its cellular uptake and impairing its renal excretion.
Corticosteroids
May enhance potassium depletion, which can increase the risk of cardiac dysfunction.
Nephrotoxic drugs
Concomitant use with other nephrotoxic agents (e.g., cyclosporine, aminoglycosides, tacrolimus) increases the risk of renal toxicity.
Digitalis glycosides
Hypokalemia induced by amphotericin B can potentiate digitalis toxicity.
Storage
Store intact vials refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light. After reconstitution, the solution is stable for 24 hours at room temperature (20°C to 25°C) or 7 days at 2°C to 8°C.
Overdose
Amphotericin B overdose may result in cardiopulmonary arrest and/or renal failure. Management includes symptomatic and supportive care, discontinuation of the drug, and close monitoring of vital signs and laboratory parameters.
Pregnancy & Lactation
Pregnancy Category B. Use in pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown if Amphotericin B is excreted in breast milk; caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months from manufacturing date when stored correctly. Refer to the specific product leaflet for precise details.
Availability
Hospitals, Clinics, Pharmacies
Approval Status
Approved
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials and decades of clinical experience have established Amphotericin B as a cornerstone therapy for severe systemic fungal infections, demonstrating efficacy against a wide range of susceptible fungi.
Lab Monitoring
- Renal function tests (blood urea nitrogen (BUN), serum creatinine, creatinine clearance) prior to therapy and at least twice weekly during therapy.
- Serum electrolyte levels (especially potassium and magnesium) frequently.
- Liver function tests (ALT, AST, alkaline phosphatase, bilirubin).
- Complete blood count (CBC) to monitor for anemia or other hematologic abnormalities.
Doctor Notes
- Always administer a test dose to assess for immediate hypersensitivity and infusion-related reactions.
- Pre-medication (e.g., acetaminophen, antihistamines, corticosteroids) may be used to mitigate infusion-related adverse events.
- Ensure adequate hydration and electrolyte supplementation (especially potassium and magnesium) to minimize nephrotoxicity.
Patient Guidelines
- Report any unusual symptoms, especially fever, chills, nausea, vomiting, or changes in urine output, immediately to your healthcare provider.
- Ensure adequate hydration as advised by your doctor to help protect your kidneys.
- Understand the importance of regular blood tests for monitoring kidney function and electrolyte levels.
Missed Dose Advice
If a dose is missed, contact your healthcare provider immediately for instructions. Do not administer a double dose to make up for a missed one.
Driving Precautions
Amphotericin B can cause dizziness, drowsiness, or visual disturbances. Patients should be advised to avoid driving or operating heavy machinery if they experience these side effects.
Lifestyle Advice
- Maintain good personal hygiene to minimize the risk of secondary infections.
- Follow all dietary and fluid intake recommendations provided by your healthcare team.
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